Recording the Number of Coils

It is important to record the number of coils from the micro-insert trailing into the uterine cavity, as well as noting any issues with identifying the tubal ostia, or concerns regarding potential perforation. These issues can be reviewed at the three-month post-procedure HSG. Additional information in the patient records should include any concern at the time of micro-insert placement of possible perforation, certain loss of resistance, or no visible trailing length after device placement. Also, the visible trailing length at the conclusion of device placement of less than three and greater then eight should be noted – as three to eight coils trailing into the uterine cavity is considered ideal placement.

Post-Procedure protocol

A patient identification card is supplied with each Essure system. This must be given to the patient and she must be advised to carry it with her at all times and show it to all healthcare providers involved in her present and future care.

Patient must be instructed to use an alternative form of contraception, except an intra-uterine device (IUD) for the first three months following the procedure. It is important to ensure that the patient is supplied with or already has contraception for this time frame. This contraception must be the most effective means for which she is a candidate (ie: oral contraception or injection Depo-provera 150mg).

The patient should be scheduled for the HSG three months after the Essure micro-insert placement procedure. The HSG is performed to evaluate micro-insert location, and fallopian tube occlusion. Only if the micro-insert location is satisfactory and there is evidence of bilateral occlusion of the tubes may the physician instruct the patient to discontinue the use of alternative contraception and rely entirely on Essure micro-inserts.

HSG Protocol

The following steps should be followed for performing and evaluating the HSG. One objective of HSG is to evaluate the relationship of the proximal end of the inner coil of the micro-insert to the uterine cornu thus verifying that the micro-insert spans the uterotubal junction. In order to achieve this, the following guidelines must be adhered to:

1) Uterine cavity silhouette must be seen with good cornual filling

2) The fluoroscopy beam should be as close to anterior-posterior projection as possible to the uterus

3) Good cervical seal must be maintained for achieving uterine distention

4) Downward traction on the cervical tenaculum may be required to obtain a mid position of the uterus for ideal images of the uterine cavity. The speculum can be removed prior to fluoroscopy to assure best possible visualization of the uterine anatomy.

5) A minimum of six still radiographs should be taken to assess micro-insert location and tubal occlusion.

The following are images of the Essure micro-insert during hysterosalpingogram with descriptions.

Radiographic view and photographic views showing proximal and distal ends of inner and outer coils.

 

Radiographic views show poor cervical seal and non-opacification of the uterine cornu.

 

Radiography showing non-distension of the cornua with the dye.

 

Radiography showing cornual distention of the uterine cavity has been achieved with adequate distention of the dye.

 

Magnification of bilateral cornua. Highlights the position of the micro-insert in reference to the uterine cornua. a. Right cornua b. Left cornua.

 

Radiography showing expulsion of micro-insert a. Complete expulsion of the left micro-insert b. expulsion of the left micro-insert into the uterus.

 

Radiography showing distal ends of inner coils within the tubes a. Proximal end is trailing into the uterine cavity b. On patient left side, proximal end of inner coil in <30mm from contrast at cornua.

Radiography showing micro-insert in peritoneal cavity a. Shows micro-insert in the peritoneal cavity b. distal placement of the micro-insert.

 

Radiography showing contrast in the proximal tube on the right side;

 

Radiography showing tubal occlusion at the cornua.

 

Contrast is seen beyond the proximal tube with spillage into the peritoneal cavity.

If the HSG does not demonstrate tubal occlusion or in other words shows tubal patency beyond the micro-insert, the patient must continue the use of alternative contraception for three additional months and repeat the HSG at six months post-procedure. If tubal occlusion is not established at six months, the patient must be advised not to rely on the Essure micro-inserts for contraception.

In a recent clinical study utilizing an improved coil catheter delivery system (which is now standard), correct device placement was confirmed in 100/102 (98%) of patients. 20 Between the two patients with failed attempts the delivery system could not be advanced to the ostia. Subsequent HSGs identified one of these patients had fibrosis with thickening of the isthmic tubal segment, and the other, tubal stenosis. The average procedure time, defined as the time from scope insertion to removal was 8.1 minutes. Of the 100 women with successful bilateral placement 94 underwent a post-procedure HSG. All but one of these women demonstrated bilateral tubal occlusion.

Satisfaction Rating of the Device

At one-week follow-up, satisfaction was rated as “very satisfied” by 94 of 100 (94%) women, and “reasonably satisfied” by the remaining six.

 

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October 2006

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